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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 078834

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NDA 078834 describes LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL, which is a drug marketed by Dr Reddys Labs Sa, Lupin Ltd, and Xiromed, and is included in seven NDAs. It is available from five suppliers. Additional details are available on the LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL profile page.

The generic ingredient in LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.

Summary for 078834

Tradename:	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
Applicant:	Dr Reddys Labs Sa
Ingredient:	ethinyl estradiol; levonorgestrel
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.03MG,0.01MG;0.15MG,N/A
Approval Date:	May 31, 2011	TE:	AB	RLD:	No

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